The FDA has expanded the administration options for Hizentra (human normal immunoglobulin 20% liquid), from CSL Behring, to include the...
The FDA has accepted the new drug application (NDA) for SH 201, the first palatable oral liquid of the related chemotherapeutic agent, for the treatment of certain forms of leukemia and other cancers
Takeda announced that the FDA has approved Gammagard Liquid[Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
The FDA has approved Gammagard Liquid 10% [Immune Globulin Infusion (Human)] as a treatment for Mmultifocal Motor Neuropathy (MMN). This is...
Additional analyses from a negative Phase III clinical trial of Gammagard Liquid/Kiovig (intravenous immunoglobulin), from Baxter, in people with mild...
GC Biopharma Corp announces that the FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI).
Bio Products Laboratory announced that the FDA has approved Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for the treatment...
Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes (PID) with impaired antibody production • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) * or serum IgG level of <4 g/l * PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines Immunomodulation in adults, children and adolescents (0-18 years) in: • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count • Guillain Barré syndrome • Kawasaki disease (in conjunction with acetylsalicylic acid; see section 4.2) • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) • Multifocal motor neuropathy (MMN)
The FDA has approved Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) from CSL Behring, as a subcutaneous immunoglobulin (SCIg) for...
Replacement therapy in adults, children and adolescents (0-18 years) in • Primary immunodeficiency (PID) syndromes with impaired antibody production (see section 4.4). • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4g/l. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines